Breast Cancer Clinical Trial
Official title:
The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors
This study is proposed to assess long-term Quality of Life issues in breast cancer survivors by measuring the impact on the quality of life made by the structured "Change Cycle Work Shop" coping class as compared to current local standard of care programs. It has been shown that breast cancer treatment can have long-term bio-psychosocial consequences. Specific evidence-based interventions are needed to address Quality of Life concerns in order to improve the overall outcome of breast cancer and its treatment beyond the focus on mortality rate.
Breast cancer is the most common cancer among North American women. A combination of
screening mammography and improvements in treatment has resulted in a substantial decrease
in mortality which explains why more women diagnosed at a younger age are becoming long-term
survivors.Consequently, quality of life (QL) issues have become increasingly important in
the contemporary multidisciplinary management of breast cancer. Standard of car survivorship
program has evolved over several years to include 3 facets: (1)clinical surveillance program
to include routine follow up exams; (2) local support group programs; and (3) rehabilitation
program offering physical and occupational rehab, along with lymphedema prevention and
treatment.
Many studies have reported on successful interventions (listed in our references) with
improvements in quality of life; however the effects did not last long after intervention.
This has brought into question the real value of such interventions. The proposed class will
focus on teaching life skills that have shown long-lasting effect in the corporate world of
change. Thus, our goal is to determine if the impact of the class will be similar in the
healthcare arena, specifically cancer survivorship. Our last study on assessing quality of
life revealed that patients were suffering deficits in quality of life, specifically with
regard to the emotional scale despite the standard of care approach available. We therefore
propose this intervention to be studied as proof of concept so that depending on the results
of the proposed trial, this class can become a routine part of the survivorship program.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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